News - ADT Biotech

LyteStar Enterovirus HFMD Typing Kit receives market authorization in Malaysia

01/2025 – To the start of the new year ADT Biotech’s LyteStar Enterovirus HFMD Typing Kit has achieved regulatory approval by the Malaysian Medical Device Authority (MDA).

The LyteStar Enterovirus HFMD Typing Kit is intended for the specific detection and subtyping of Enterovirus RNA in human throat, vesicles, lesions or rectal swabs in VTM, and blood and cerebrospinal fluid (CSF) specimens. The LyteStar™ Enterovirus HFMD Typing RT-PCR Kit 1.0 is a four-target assay comprising a screening assay targeting pan-Enterovirus 5’ UTR region, and a typing assay that further differentiates Enterovirus serotypes A71 (EV71), via targeting of the VP3-VP1 genes, and Coxsackievirus A16 (CVA16) and Coxsackievirus A6 (CVA6), via targeting the VP1 gene. The kit includes an Internal Control detected in the 5th fluorescent channel.

LyteStar Influenza Typing RT-PCR Kit achieves market authorization in Thailand

07/2024 – ADT Biotech’s LyteStar Influenza Typing RT-PCR Kit is now available in Thailand after achieving regulatory approval by the Thailand Food and Drug Administration (Thai FDA).

LyteStar Arbovirus ZCD Kit achieves MDA approval in Malaysia

05/2024 – ADT Biotech’s recently introduced product, the LyteStar Arbovirus ZCD Kit has obtained market authorization by the Malaysian Medical Device Authority (MDA).

The LyteStar Arbovirus ZCD Kit has been developed for the specific detection and differentiation of the three mosquito-borne viruses Dengue, Chikungunya and Zika in a single reaction format. The assay targets a conserved 3’UTR region specific for all four Dengue serotypes (DEN 1 – 4), the NSP2-gene specific for CHIKV, the E-gene specific for Zika virus and is complemented by an Internal Control in the 4th detection channel.

LyteStar COVID / Flu / RSV Differentiation Kit obtains market authorization in Malaysia

02/2024 – ADT Biotech’s latest product, the LyteStar COVID / Flu / RSV Differentiation Kit has achieved regulatory approval by the Malaysian Medical Device Authority (MDA).

The LyteStar COVID / Flu / RSV Differentiation RT-PCR Kit is a four-target assay intended for the specific detection of SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV) RNA in human respiratory specimens, comprising of detection and differentiation assays targeting the SARS-CoV-2 specific RNA-dependent RNA polymerase (RdRP) gene, the Influenza A specific Matrix (M) gene, the Influenza B specific Haemagglutinin (HA) gene and the RSV specific Matrix (M) gene.

LyteStar Dengue Typing RT-PCR Kit achieves MDA approval in Malaysia

01/2024 – ADT Biotech’s recently launched LyteStar Dengue Typing RT-PCR Kit has achieved market authorization by the Malaysian Medical Device Authority (MDA).

The LyteStar Dengue Typing RT-PCR Kit is a multiplex kit intended for the simultaneous and specific detection and differentiation of the four Dengue virus serotypes (DENV 1-4) in human serum specimens. The kit comprises a four-target assay targeting the 5’UTR/capsid gene of DENV1 and DENV4, envelope (E) gene of DENV2 and protein membrane (prM) gene of DENV3 as well as an Internal Control in a single reaction.

LyteStar Influenza Typing RT-PCR Kit achieves MDA approval in Malaysia

10/2023 – ADT Biotech’s LyteStar Influenza Typing RT-PCR Kit has achieved regulatory approval by the Malaysian Medical Device Authority (MDA).

The LyteStar Influenza Typing RT-PCR Kit is intended for the specific detection of Influenza A/B RNA in human respiratory specimens including deep nostrils (nasal swab), throat (oropharyngeal swab) and nasopharyngeal swabs placed in VTM, nasopharyngeal wash/aspirate, nasal wash/aspirate and bronchial aspirate. The LyteStar Influenza Typing RT-PCR Kit is a four-target assay comprising a screening assay targeting the Influenza A matrix (M) and Influenza B hemagglutinin (HA) genes and further differentiates Influenza A into A(H1N1)pdm09 and H3N2 in a single reaction.

LyteStar MERS-CoV RT-PCR Kit obtains regulatory approval in Malaysia

04/2023 – ADT Biotech’s LyteStar MERS-CoV RT-PCR Kit has achieved market authorization by the Malaysian Medical Device Authority (MDA).

The LyteStar MERS-CoV RT-PCR Kit is a dual-target assay intended for the specific detection of MERS-CoV RNA in human respiratory specimens, comprising a screening assay targeting the upE gene and a confirmatory assay targeting the Orf1a gene as well as an Internal Control in a single reaction.

LyteStar 2019-nCoV RT-PCR Kit achieves ICMR approval and CDSCO import license in India

04/2020 – After successful validation by the Indian Council of Medical Research (ICMR), the Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, India, has granted ADT India an import license for the LyteStar 2019-nCoV RT-PCR Kit and the LyteStar SARS-CoV-2 RT-PCR Kit S. ADT’s LyteStar 2019-nCoV RT-PCR Kit has since been included in the ICMR list of validated and approved detection kits of SARS-CoV-2 RNA by Real Time PCR.

The LyteStar 2019-nCoV RT-PCR Kit adopts a dual target strategy, targeting the E-gene of SARS-related Coronaviruses for the broader screening assay and the RdRP-gene for the SARS-CoV-2 (earlier 2019-nCoV) specific confirmation test. The screening assay (E-gene) is also separately available as the LyteStar SARS-CoV-2 RT-PCR Kit S (Screen) for flexible testing algorithms and best utilization of reagents and resources.

MOH Malaysia awards ADT Biotech to supply LyteStar 2019-nCoV RT-PCR Kit

03/2020 – Ministry of Health (MOH) Malaysia has awarded ADT Biotech to supply its LyteStar 2019-nCoV RT-PCR Kit to all centers under MOH jurisdiction authorized to test for SARS-CoV-2, the virus causing COVID-19. Preceding the award, the LyteStar 2019-nCoV RT-PCR Kit had been validated by the Institute for Medical Research (IMR) with concordant results against IMR’s reference test.

The LyteStar 2019-nCoV RT-PCR Kit adopts a dual target strategy, targeting the E-gene of SARS-related Coronaviruses for the broader screening assay and the RdRP-gene for the 2019-nCoV specific confirmation test.

ADT Biotech launches dual target assay for novel Coronavirus SARS-CoV-2

02/2020 – ADT Biotech has launched a kit for detection of 2019-nCoV (recently named SARS-CoV-2) based on WHO interim guidelines recommending a test algorithm using a screening test for a broader detection of SARS-related Coronaviruses followed by a highly specific confirmation test.

The LyteStar 2019-nCoV RT-PCR Kit adopts a dual target strategy, targeting the E-gene of SARS-related Coronaviruses for the broader screening assay and the RdRP-gene for the 2019-nCoV specific confirmation test. The kit is available as a complete dual target kit, but the kit components allowing for the detection of E-gene only are separately available as a screening kit, i.e.. the LyteStar SARS-CoV-2 RT-PCR Kit S (for Screen) hence offering greatest flexibility in choosing the most appropriate testing algorithm and optimal reagents utilization.

ADT Biotech launches first molecular detection kit for Scrub Typhus

01/2020 – With the LyteStar Scrub Typhus PCR Kit, ADT Biotech is launching the first realtime PCR based molecular diagnostic kit for the specific detection of Orientia tsutsugamuchi, the causative agent of Scrub typhus.

Scrub typhus is caused by infection with the bacteria Orientia tsutsugamushi, following the bite of an infected trombiculid mite during its larval stage. Geographic distribution of the disease spans the entire Asia Pacific region, Middle East, Africa and South America. Symptoms include fever, headache, maculopapular rash, eschar (lesion), lymphadenopathy, and complications involving the central nervous system. A molecular test offers fast, sensitive and highly specific diagnostic results, overcoming limitations of current serological tests.

PathoNostics AsperGenius Kit now registered in Taiwan

12/2019 – PathoNostics AsperGenius Kit has achieved market authorization in Taiwan after registration with the Taiwan Food and Drug Administration.

The AsperGenius is a CE IVD certified product for the detection and identification of Aspergillus fumigatus, Aspergillus terreus, Aspergillus species and the most prevalent azole resistance markers L98H/TR34 and TR46/Y121F/T289A. The product has been extensively clinically validated and is a proven tool for the diagnosis and management of Invasive Aspergillosis.

ADT Biotech now ISO 13485 certified

08/2019 – After the successful certification audit in July 2019 ADT Biotech has achieved the Certificate of Registration for operating a Quality Management System in compliance with the requirements of ISO 13485:2016.

PathoFinders GastroFinder kit now registered in Malaysia

06/2019 – ADT Biotech has achieved product registration in Malaysia for the GastroFinder 2SMART kit, a RealTime PCR based multiple assay to detect 18 gastrointestinal pathogens, manufactured by PathoFinder, The Netherlands.

With this latest registration by the Medical Device Authority, all PathoFinder multiplex panels have obtained market authorization in Malaysia. Next to the GastroFinder, PathoFinder offers the RespiFinder for 22 respiratory pathogens, the MeningoFinder for 22 pathogens causing Central Nervous System infections and the STD-Finder for the most important Sexually Transmitted Disease pathogens.

ADT Biotech launches LyteStar HCV Genotyping Kit

04/2019 – ADT Biotech’s recently launched LyteStar^TMHCV Genotyping Kit is a ready-to-use real-time PCR kit for the detection and identification of HCV Genotypes 1 – 6, and further typing of Subtypes 1a and 1b. In addition to the genotype specific assays, the kit contains an amplification system for all HCV genotypes (HCV consensus) and an Internal Control to monitor extraction efficiency, potential PCR inhibition and the integrity of all kit components.

GeneProof HBV and HCV kits obtain CDSCO approval in India

03/2019 – GeneProofs kits for detection and viral load determination of Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) are now available in India. Both products have been granted an import license by the Central Drugs Standard Control Organization (CDSCO) in March 2019.

GeneProof kits obtain import license in Thailand

01/2019 – GeneProofs complete product range of CE IVD certified products has been granted market authorization in Thailand by registration under Thai FDA.

LyteStar TB/NTM kit now registered in Thailand

07/2018 – ADT’s LyteStar TB/NTM kit has achieved market authorization in Thailand by registration under Thai FDA.

PathoNostics kit obtains market approval in Malaysia

06/2018 – PathoNostics AsperGenius kit has achieved market authorization in Malaysia with registration by the Medical Device Authority (MDA).

PathoFinder kits now registered in Malaysia

06/2018 – PathoFinders RespiFinder, MeningoFinder and STD-Finder kits have been registered with the Medical Device Authority (MDA) in Malaysia.

PathoFinder kits achieve registration in Thailand

02/2018 – PathoFinders RespiFinder, MeningoFinder and STD-Finder kits have achieved regulatory approval by Thai FDA in Thailand.

GeneProof HIV kit now registered in Malaysia

02/2018 – GeneProof HIV kit has achieved market authorization in Malaysia with registration by the Medical Device Authority (MDA).

GeneProof HBV and HCV kits obtain market authorization in Malaysia

12/2017 – GeneProof HBV and HCV kits have achieved product registration with Medical Device Authority (MDA) in Malaysia.

PathoNostics kits now registered in India

12/2017 – PathoNostics AsperGenius, PneumoGenius and DermaGenius kits achieve market authorization in India under the Central Drugs Standard Control Organization (CDCSO).

PathoFinder kits achieve registration in India

12/2017 – PathoFinders RealAccurate Quadruplex Corona and RSV/hMPV kits achieve market authorization in India under the Central Drugs Standard Control Organization (CDCSO).

GeneProof kits achieve import license in India

11/2017 – GeneProof non-notified in vitro diagnostic kits achieve Import License in India under the Central Drugs Standard Control Organization (CDCSO).

PathoNostics kits achieve registration in Australia

11/2017 – PathoNostics AsperGenius and DermaGenius kits have achieved registration in the Australian Register of Therapeutic Goods (ARTG).